Neural injection system and related methods

ABSTRACT

A novel neural injection system and related methods are herein disclosed. Various embodiments of an embodiment of a neural injection system of the present invention provide for at least one benefit of enhanced injection characteristics, increased operational efficiency, reduced cost per unit, reduced incidence of injury through intraneural/intravascular injection, reduced incidence of injury through pricking/piercing, and/or the like.

RELATED APPLICATIONS

This application claims priority to, and incorporates by reference, U.S.Provisional Application No. 60/843,642 filed Sep. 11, 2006, and U.S.Nonprovisional application Ser. No. 11/853,671 filed Sep. 11, 2007.

SUMMARY OF THE INVENTION

Endoscopic surgery is widely practiced throughout the world today andits acceptance is growing rapidly. In general, endoscopic surgeryinvolves one or more incisions made by trocars (cannulae carrying sharpobturators) where the cannulae are left in place to provide instrumentports so that endoscopic surgical instruments may be inserted into thebody. An endoscope is often inserted through one cannula, while acutter, dissector, or other surgical instrument is inserted throughanother cannula for purposes of manipulating and/or cutting an internalorgan. Sometimes it is desirable to have several cannulae in place atonce in order to receive several surgical instruments. In this manner,organs or tissue may be grasped with one surgical instrument, andsimultaneously may be cut with another surgical instrument, all underview of the surgeon via the endoscope. In order to enlarge the closedspace surrounding the surgical site, a pneumoneedle (or Veress needle)is inserted into the body cavity and the cavity is insufflated byinjecting gas (typically C0 into the cavity through the Veress needle).At the conclusion of the procedure, the body cavity is desufflated(aspirated) by opening a valve on one or more trocar cannulae.

A very successful embodiment of a needle with an opening at the distalend portion and with a side port is disclosed in U.S. Pat. No. 5,817,074(“the '074 patent”). The '074 patent discloses a stellate ganglionsympathetic block needle having a side port positioned at apredetermined distance from the needle distal. The stellate ganglionsympathetic block needle allows for an effective stellate ganglionsympathetic block even if the needle is placed such that the needledistal opening is under the anterior longitudinal ligament, whichresults in the needle distal opening being constricted, therebyinterfering with the injection of the anesthesia. When this interferenceoccurs, the side port of the novel stellate ganglion sympathetic blockneedle allows directional injection onto the surface of the anteriorlongitudinal ligament in order to spread onto the surface of the longuscoli muscle toward the stellate ganglion, thereby achieving an effectivestellate ganglion sympathetic block. This invention has found wideapplicability, however, certain procedures might prefer or require ablunt needle without an opening at the distal end portion.

It is known to have needles with a blocked tip (distal end) and with aside opening, Such needles are used for procedures such asthoracentesis, which involves inserting the needle through the thoraciccage into the pleural space between the lung and the chest wall to drawoff fluid for diagnostic or therapeutic purposes. Thoracentesis needlesgenerally consist of an orifice free, sharp conical end and a circularside hole for draining fluid.

U.S. Pat. No. 5,573,519 discloses an elongated, hollow spinal needlehaving a modified, pencil-like point with a rounded shoulder at thejuncture between the modified, pencil-like point and the body of thespinal needle. A side port formed in the hollow needle is adjacent therounded shoulder, extending from the rounded shoulder. Further, theleading edge of the side port is located not more than 1.5 times theexternal diameter of the hollow needle from the tip (distal end) of thepencil-like point to reduce the potential bending moment between the tipand the side port. The cross sectional area of the side port isconfigured to be about equal to the cross sectional area of the lumen ofthe hollow needle.

U.S. Pat. No. 5,800,407 discloses an epidural catheter that purportedlycombines the benefits of the open-end and closed-end three lateral holestype catheters. The epidural catheter is stated as being designed toinclude an end hole and a plurality of lateral holes. The combined endand multiple lateral holed epidural catheter of the present inventionincludes seven holes within a 1.5 cm head. The holes are positionedalong the head such that one hole is provided at the tip, three lateralholes are circumferentially arranged about the head at approximately 1mm from each other, and three additional holes are axially displacedfrom one another by approximately 4 mm. All the holes are within the 1.5cm from the tip. The radius of each of the lateral holes is the same,thus, the anesthetic solution stream is the same from each hole.

Further, needles with retractable stylets and/or blades have been longknown in the art. For example, U.S. Pat. No. 4,909,793 (the '793 patent)discloses an intravenous catheter apparatus having a retractable stylet,comprising a cannula member positioned at the end of a catheter, affixedto an end portion of a stylet body and engaged to an end portion of atubular stylet protector chamber. The stylet protector chamber of the'793 patent includes a stylet body plunger member having a stylet bodyand stylet on the distal end thereof, the stylet insertable in the boreof the cannula, and extending past the distal end of the cannula whenthe stylet is in the full extended position.

U.S. Pat. No. 4,924,881 discloses an implantable endocardial lead withretractable fixation device. The fixation device comprises a sharpenedhelix which can be repeatedly both retracted within a distal end of thelead and displaced outside the lead. A threaded stylet passes through alumen from a proximal end of the lead to the distal end of the lead,where the threaded stylet is screwed into a piston supporting the helix.When the helix is in an exposed position, torque can be transmitted fromthe proximal end of the lead through the distal end to the piston andthence to the helix to screw the helix into the endocardial tissue.

U.S. Pat. No. 4,967,766 discloses an implantable endocardial lead withretractable fixation apparatus. The fixation apparatus comprises asharpened helix that can be repeatedly both retracted within anelectrode at a distal end of the lead and displaced outside theelectrode by action of a flexible, tubular lanyard. The lanyard passesthrough a lumen from a proximal end of the lead to the distal end of thelead, where the lanyard is attached to a piston supporting the helix. Atthe proximal end of the lead, a jig moves the lanyard with respect to alongitudinal axis of the lead. When the helix is in an exposed position,torque can be transmitted from the proximal end of the lead to thedistal end thereof, through the electrode to the piston and then to thehelix to screw the helix into the endocardial tissue. To stiffen thelead during implantation, a stylet can be inserted into a lumen in thelanyard.

U.S. Pat. No. 5,129,404 discloses an implantable endocardial lead withretractable sharpened helix. The piston has a central bore for receivinga specialized stylet. The stylet comprises a flexible wire having anenlarged distal end or tip. An elastomeric sliding sleeve fits over thewire. When the proximal end of the stylet is inserted into the bore inthe piston, the wire can be withdrawn slightly, pulling the enlarged tipinto the tube, and wedging the tube against the walls of the bore. Bymanipulating the stylet, the helix can be exposed outside of the lead,or retractable into the lead, as desired.

U.S. Pat. No. 5,228,455 discloses an implant tool for use with anendocardial or other implantable lead having an extendable/retractablepositive fixation tip including a hollow cylindrical housing and acustom designed stylet. The cylindrical housing attaches to a proximalend of the implantable lead. The stylet is inserted through the implanttool and into a lumen of the lead. The presence of the stylet, made froma length of relatively stiff wire, helps guide the distal tip of thelead to a desired implant location. The cylindrical housing includes abody portion and an end portion. The end portion is rotatable relativeto the body portion. The stylet includes a knob on its proximal end, andalso includes a stub pin slightly forward of its proximal end. The stubpin is received within a slot along the side of the cylindrical housing.Two spaced-apart recesses along the length of the slot allow the stubpin to be respectively held therein. When the stub pin is held in afirst recess, the stylet wire has advanced sufficiently far into thelead to facilitate implantation of the lead, but retains the positivefixation tip in its retracted position. When the stub pin is locked in asecond recess, the stylet wire has advanced sufficiently far into thelead to engage the positive fixation tip and move it to its extendedposition. A method of using the implant tool is also disclosed.

U.S. Pat. No. 5,344,439 discloses a catheter with a retractable anchormechanism for providing drugs and/or electrical stimulation to the humanbody. The catheter has a flexible tubular casing consisting of an outermember and an inner member which enclose at least one lumen. Theretractable anchor mechanism is located near the distal end of thecatheter and is moveable from a first extended position to a secondretracted position. A capture member is connected to the anchormechanism. The capture member has a socket portion and a necked downportion for guiding the enlarged tip of a stylet into the socket portionfor releasable engagement therewith. The anchor mechanism is moved fromthe first extended position to the second retracted position byinserting a stylet and applying pressure in the distal direction and ismoved from the second retracted position to the first extended positionby partially withdrawing the stylet thereby applying pressure in theproximal direction. The anchor mechanism consists of a plurality oflobes in one embodiment and of a continuous diaphragm in another.

Further examples of retractable stylets and/or cutting portions include,but are not limited to, U.S. Pat. No. 4,781,692; U.S. Pat. No.4,909,793; U.S. Pat. No. 6,383,145; U.S. Pat. No. 6,551,253; and U.S.Pat. No. 6,968,238.

However, none of these prior art solutions significantly reduce a riskof injury from a sharp blade and/or edge of an injection system orprovide an enhanced medical instrument for neural injection.

Therefore, it would be advantageous to design a needle/neural injectionsystem, which can effectively inject a medicament with less concern foran intraneural and/or an intravascular injection.

Accordingly, various embodiments of the present invention comprise aneural injection system comprising an at least partially hollow cannulabeing defined by a first inside diameter, a first outside diameter, anda first length, and a side port located coaxially along the cannula forfluid communication from inside said at least partially hollow cannulato outside said at least partially cannula, wherein said cannula has arounded open blunt distal end; and a stylet, wherein the stylet iscapable of being releasably locked in a first position within saidcannula. Further embodiments comprise an introducer, the introducerbeing defined by a second inside diameter, a second outside diameter,and a second length, wherein the said second inside diameter is largerthan said first outside diameter, wherein the introducer is used foraccess across a tissue of a patient that cannot be punctured by therounded open blunt distal end during a normal insertion procedure.Various embodiments of the present invention provide for at least onebenefit of enhanced injection characteristics, increased operationalefficiency, reduced cost per unit, reduced incidence of injury throughintraneural/intravascular injection, reduced incidence of injury throughpricking/piercing, and/or the like.

Various embodiments of the present invention further comprise methods ofuse. In an exemplary, non-limiting embodiment of a method of the presentinvention wherein a patient is in need of treatment by a medicament, themethod comprises the steps of placing the patient in a supine positionand/or extended position; locating a site for injection; inserting atleast a portion of the blunt needle into the site; and injecting themedicament into the patient. Further embodiments comprise stimulatingthe site and/or ablating the site.

In further embodiments, the patient is in need of access to a particulartissue.

In various other embodiments, the invention's blunt surgical needleand/or blunt surgical assemblage is ideally suited for injection intotissue of medicaments containing nucleic acid encoding a therapeuticagent (or cells containing such nucleic acid), For example, theinvention needle (when attached to an appropriate catheter) or inventionsurgical assemblage can be used to inject medicament(s) into the wall ofa beating heart or other internal organ, without substantial loss of themedicament at the surface of the body wall and without substantialdamage to tissue at the injection site caused by injectate.

BRIEF DESCRIPTION OF THE FIGURES

In order that the manner in which the above-recited and otherenhancements and objects of the invention are obtained, a moreparticular description of the invention briefly described above will berendered by reference to specific embodiments thereof which areillustrated in the appended drawings. Understanding that these drawingsdepict only typical embodiments of the invention and are therefore notto be considered limiting of its scope, the invention will be describedwith additional specificity and detail through the use of theaccompanying drawings in which:

FIG. 1 is an illustration of a distal portion of a blunt needle of anembodiment of a neural injection system of the present invention;

FIG. 2 is an illustration of a distal portion of a blunt needle of aneural injection system of an alternate embodiment of the presentinvention;

FIG. 3 is an illustration of an alternate embodiment of a distal portionof a blunt needle of a neural injection system of an embodiment of thepresent invention;

FIG. 4 is an illustration of an alternate embodiment of a distal portionof a blunt needle of a neural injection system of an embodiment of thepresent invention;

FIG. 5 is an illustration of an alternate embodiment of a blunt needleof the present invention;

FIG. 6 is an illustration of an alternate embodiment of a blunt needleof the present invention;

FIG. 7 is an illustration of a cross-section of an alternate embodimentof a blunt needle of the present invention with an incorporatedintroducer; and,

FIG. 8 is an illustration of a cross-section of an alternate embodimentof the present invention wherein the stylet is capable of being used asthe introducer.

DETAILED DESCRIPTION OF THE INVENTION

The particulars shown herein are by way of example and for purposes ofillustrative discussion of the preferred embodiments of the presentinvention only and are presented in the cause of providing what isbelieved to be the most useful and readily understood description of theprinciples and conceptual aspects of various embodiments of theinvention. In this regard, no attempt is made to show structural detailsof the invention in more detail than is necessary for the fundamentalunderstanding of the invention, the description taken with the drawingsmaking apparent to those skilled in the art how the several forms of theinvention may be embodied in practice.

The following definitions and explanations are meant and intended to becontrolling in any future construction unless clearly and unambiguouslymodified in the following examples or when application of the meaningrenders any construction meaningless or essentially meaningless. Incases where the construction of the term would render it meaningless oressentially meaningless, the definition should be taken from Webster'sDictionary 3^(rd) Edition.

As used herein the term, “air” means and refers to a gaseous mixturethat comprises at least about 20 mole percent O₂,

As used herein, the term “attached,” or any conjugation thereofdescribes and refers to the at least partial connection of two items.

Exemplary, non-limiting embodiments of medical instrument, neuralinjection systems, and/or the like that can be modified according tovarious teachings of the present invention include, but are not limitedto, U.S. Pat. No. 6,949,087; U.S. Pat. No. 6,855,132; U.S. Pat. No.6,558,353; U.S. Pat. No. 6,547,769; U.S. Pat. No. 6,387,163; U.S. Pat.No. 6,245,044; U.S. Pat. No. 5,871,470; U.S. Pat. No. 5,865,806; U.S.Pat. No. 5,836,914; U.S. Pat. No. 5,817,074; U.S. Pat. No. 5,800,445;U.S. Pat. No. 5,730,749; U.S. Pat. No. 5,669,882; U.S. Pat. No.5,628,734; U.S. Pat. No. 5,573,519; U.S. Pat. No. 5,571,091; U.S. Pat.No. 5,480,389; U.S. Pat. No. 5,466,225; U.S. Pat. No. 5,336,191; U.S.Pat. No. 5,312,360; U.S. Pat. No. 5,304,141; U.S. Pat. No. 5,250,035;U.S. Pat. No. 5,242,410; U.S. Pat. No. 5,106,376; U.S. Pat. No.4,994,034; U.S. Pat. No. 4,973,313; U.S. Pat. No. 4,629,450; U.S. Pat.No. 4,317,445; U.S. Pat. No. 4,308,875; U.S. Pat. No. 4,230,123; U.S.Pat. No. 3,856,009; U.S. Pat. No. 3,565,074; and, U.S. Pat. No.2,922,420, the contents of which are hereby incorporated by reference asif they were presented herein in their entirety. In general, anycatheter may be used with the various embodiments of the presentinvention.

As used herein, the term “CO” means and refers to carbon dioxide in anyform, i.e., gas or liquid.

As used herein, the term “fixation apparatus” means and refers to anapparatus for connecting to and at least partially rigidly supportingfixation structure further including a support for rigidly connectingthe cast to the frame and biasing structure operable between the headand the frame and/or the fixation structure to bias the cast intopositive contact with the upper teeth and/or palate. The apparatus isused in stereotatic diagnosis and treatment.

As used herein, a “fluid” is a continuous, amorphous substance whosemolecules move freely past one another and that has the tendency toassume the shape of its container, for example, a liquid or a gas.

As used herein, the term “medicament(s)” means and refers to all typesof fluidic substances that have a beneficial, desired or therapeuticeffect. Non-limiting examples of medicaments suitable for use in theinvention methods include anesthesia, biologically active agents, suchas small molecule drugs, proteinaceous substances, polynucleotides ornucleic acids (e.g. heterologous DNA, or RNA) and vectors, liposomes,and the like, containing such nucleic acids or polynucleotides, as wellas liquid preparations or formulations thereof.

As used herein, the term “medical instrument” means and refers to anyitem, instrument or structure capable of connecting to a catheter, suchas, but not limited to a stimulation device, tubing, piping, amedicament delivery system, a meter, a liquid repository (such as anI.V. bag), a syringe, and/or the like.

As used herein, the term “normal insertion procedure” means and refersto a typical surgical and/or insertion procedure as disclosed in Heavneret al., “Sharp Versus Blunt Needle: A Comparative Study of Penetrationof Internal Structures and Bleeding in Dogs”, 2003, World Institute ofPain, Pain Practice, 3:3, 226-231.

As used herein, the term “stylet” means and refers to a small poniard.Stylets of the present invention are capable of being hollow, but suchis not required.

Other than in the operating examples, or where otherwise indicated, allnumbers expressing quantities of ingredients or reaction conditions usedherein are to be understood as modified in all instances by the term“about”.

In general, various embodiments of a device of the present inventioncomprise neural injection and/or treatment systems and related methodswith at least one benefit of enhanced injection characteristics,increased operational efficiency, reduced cost per unit, reducedincidence of injury through intraneural/intravascular injection, reducedincidence of injury through pricking/piercing, and/or the like.

More particularly, embodiments of the present invention generallycomprise a neural injection system comprising an at least partiallyhollow cannula being defined by a first inside diameter, a first outsidediameter, and a first length, and a side port located coaxially alongthe cannula for fluid communication from inside said at least partiallyhollow cannula to outside said at least partially hollow cannula,wherein said cannula has a rounded open blunt distal end; a stylet,wherein the stylet is capable of being releasably locked in a firstposition within said cannula; and, an introducer being defined by asecond inside diameter, a second outside diameter, and a second length,wherein the introducer is used for access across a tissue of a patientthat cannot be punctured by the rounded open blunt distal end during anormal insertion procedure. In further embodiments, the neural injectionsystem further comprises a medical instrument, i.e., any item,instrument or structure capable of connecting to a connector, such as,but not limited to a stimulation device, tubing, piping, a medicamentdelivery system, a meter, a liquid repository (such as an I.V. bag), asyringe, and/or the like connected to the connector end.

Various embodiments of the invention methods and devices are designedfor injection of minute amounts of fluid medicaments into tissue or abody wall, for example, an interior body wall. The therapeutic amount ofthe medicament to be administered according to the invention method willvary depending upon the therapeutic goal to be accomplished, the sizeand age of the subject, the pharmacokinetics of the injectate, and thelike. However, a therapeutic amount according to the present inventionis typically in the range from about 0.1 cc to about 5.0 cc.

Various other embodiments are designed for treatment of a targettissue(s). In an embodiment, treatment of a tissue comprises at leastone of probing, ablation, stimulating, and/or the like. In general,treatments capable with various embodiments of the present invention canbe any treatment common in the art and should not be limited by thepresent disclosure.

A cannula associated with various embodiments of a neural injectionsystem is generally a cylindrical structure extending from a proximalend to a distal end. In an embodiment, the cannula is of a generallyconstant circumference. The cannula is capable of being differentiatedby an inside diameter and an outside diameter. In an embodiment, anoutside diameter is between about 0.0355 to about 0.03600 mm and aninside diameter is between about 0.0230 to about 0.0245 mm. In analternate embodiment, an outside diameter is between about 0.0205 to0.280 mm and an inside diameter between about 0.0155 to 0.0170 mm.Generally, an inside diameter and an outside diameter are capable ofbeing any desired length and any particular length should not beconstrued as a limitation on the scope of the appended claims.

In an embodiment of the present invention, a tip end or distal end ofthe at least partially hollow cannula comprises a rounded portion, suchas a shoulder, about the end of the first length, generally extendingcircumferentially around the cannula. In an embodiment, the roundedportion is smooth. In an alternate embodiment, the portion is at leastpartially roughened. In an alternate embodiment, at least one generallybeveled edge extends along the portion. In an embodiment of a portionwith a bevel, the beveled edge extends circumferentially about theshoulder whereby the point of the tip is still capable of being insertedinto at least one tissue of a patient, but the exposed edge or point isnot as sharp as a needle point.

In an embodiment, a connector is about the proximal end of the cannula.A connector of the present invention comprises an attachment means forattaching the cannula and an optional further medical instrument. Theconnection or connections at the connector end may be any type ofconnection common in the art, such, as for example, and not by way oflimitation, a luer lock connector, a threaded attachment, aninterference fit attachment, a clamp, a system utilizing a dowel, two ormore of the aforesaid in combination, and/or the like.

A stylet of various embodiments of the present invention generallyextends through at least a portion of the hollow portion of the cannula.In an embodiment, a stylet of the present invention is generallycharacterized by an outside diameter and a length extending from aproximal end to a distal end, wherein the outside diameter is smallerthan the first inside diameter of the cannula. In various embodiments,the stylet comprises a side port and is at least partially hollow. In anembodiment, the stylet and the cannula define a passageway for passageof at least one medicament.

In general, various embodiments of stylets of the present invention arecapable of being inserted to any desired location within the cannula. Inan embodiment, the distal end of the stylet is flush with the shoulderof the distal end of the cannula. In an alternate embodiment, the distalend of the stylet extends past the shoulder of the distal end of thecannula. In an alternate embodiment, the shoulder of the distal end ofthe cannula extends past the distal end of the stylet. Variousembodiments of the present invention either fixedly connect, releasablyconnect, or leaves unconnected the stylet and the cannula. Accordingly,in an embodiment, the stylet is capable of sliding within the cannula.In an alternate embodiment, the stylet is releasably secured within thecannula by a locking mechanism, such as, but not limited to a luer lock,an interference fit, a snap, screw threads, and/or the like. In anembodiment of a luer lock system, internal male luer threads are locatedin or about the stylet adjacent to receive and engage a cannula havingfemale luer threads thereon. In alternate embodiments, the luer lock isreversed. In an alternate embodiment, the cannula is welded to orotherwise fixedly connected to the cannula.

A side port of the present invention is generally a port extending fromthe exterior of the cannula to the interior of the cannula and/orstylet. The shape of the side port can vary. In an embodiment, a port iscircular. In an alternate embodiment, a port is ovular. In an alternateembodiment, a port is a quadrangular port, such as a rectangle or asquare. In an alternate embodiment, the port is triangular. In general,ports of the present invention can be any shape sufficient to permitfluid aspiration therethrough.

A side port of the present invention may be further characterized by theassociated edge of the port on the cannula and/or stylet. In anembodiment, a port has a slightly inwardly beveled edge extending fromthe exterior surface of the cannula to the interior surface. In analternate embodiment, a port has a slightly outwardly beveled edgeextending from the interior surface of the cannula to the exteriorsurface. In an embodiment, the degree of bevel can be used to change thepressure of the medicament as it enters the target tissue; facilitate achange in the degree of spread of the medicament; and, allow for asmooth surface as the cannula is inserted to the target tissue.

Further embodiments of the present invention comprise a cannula and/orstylet with multiple ports arranged in any orientation about the shaft.Further embodiments comprise a porous portion, such that the port is oneof multiple ports and a medicament introduced into the neural injectionsystem would tend to ooze out of the cannula into the target tissue.Accordingly, an embodiment comprises a blunt cannula with a weeping tipportion for microinjection of medicaments into a tissue.

In an embodiment, the neural injection system comprises a nonporoushollow cannula having a connector end adapted to mate with a neuralinjection system, a porous distal end in fluid-tight connection to thecannula, and a closed distal portion. The porous distal end of theneural injection system is adapted to cause a liquid injectate to weepor ooze therefrom multidirectionally under injection pressure while thedistal portion is inserted into a tissue. In an embodiment, the porousdistal end oozes at a substantially uniform rate.

In an embodiment, a stylet comprises, in application, a side port acrossa cannula and a side port across the stylet. In various embodiments, theside ports are positioned such that reasonable alignment of the sideports occurs at a desired position of the stylet within the cannula suchthat a medicament may pass from across the reasonably aligned sideports.

Certain tissues in a patient's body require an introducer to make a slitand/or hole prior to insertion of a novel blunt cannula of the presentinvention. In an embodiment, a separate introducer is included, theintroducer being defined by a second inside diameter, a second outsidediameter, and a second length, wherein the said second inside diameteris larger than said first outside diameter, wherein the introducer isused for access across a tissue of a patient that cannot be punctured bythe rounded open blunt distal end during a normal insertion procedureand wherein the second inside diameter is larger than the first outsidediameter.

In an embodiment, the introducer is integral with a neural injectionsystem of the present invention. In an embodiment, an introducer ispositioned surrounding a cannula and is slidable from within about abody of a neural injection system to engage a patient's tissue.Typically in such an embodiment, the introducer slides from the neuralinjection system to a position past a distal end of the cannula toengage a tissue of the patient. In an embodiment, the introducer ismaintained within a housing of the neural injection system such that thedistal portion of the introducer is only exposed during a procedurerequiring the introducer to puncture a tissue, thereby minimizing theinjuries resulting from prior art exposed introducers.

In embodiments where the introducer is a portion of the neural injectionsystem, the introducer can be extended by various methods, such as, butnot limited to physical means, pneumatic means, mechanical means,hydraulic means, electronic means, and/or the like. Generally, anymethod of extending a medical instrument can be used. Typically, thesame method used for extension is capable of being used for retractionof the introducer. In preferred embodiments, the introducer ismaintained in relation to the cannula such that no exposed sharp edge(s)of the introducer is capable of being contacted by a user, therebyminimizing accidental punctures and/or pricks by the introducer.

In yet an alternate embodiment, the introducer is positioned inside orwithin the cannula, thereby creating a slit in the tissue slightlysmaller than the cannula, but minimizing the hole and trauma to thepatient's tissue.

In various embodiments, the size of the neural injection system isimportant. To minimize size, an introducer is capable of being aseparate medical instrument. Alternately, to minimize size and reducethe need for multiple medical instruments, a stylet can be used as anintroducer.

Accordingly, in various embodiments, at least a portion of a stylet isedged, such that at least a portion of the distal edge of the stylet iscapable of penetrating a tissue that a normal insertion procedure couldnot penetrate. In an embodiment, the distal end of the stylet has atleast one bevel. In an alternate embodiment, the distal end of thestylet is a point. Generally, in embodiments characterized as such, atleast a portion of the distal end of the stylet can be of any shapecapable of penetrating a tissue that a normal insertion procedure couldnot penetrate.

Embodiments of connectors of the present invention optionally furthercomprise at least one wing. A wing of the present invention may be anystructure. In an embodiment, the wing is an extension of the connector,such as, but not limited to, a rigid flap, a rigid bar, a flexible flap,a flexible bar, and/or the like. In further embodiments, at least twowings extend from about the connector, such as, for example, and not byway of limitation, two wings extending evenly spaced circumferentiallyabout the connector. Further embodiments have various numbers of wingsextending from, attached to, or secured to the connector in variousarrangements.

In an embodiment, one wing extends from about a proximal end of acannula. A single wing connector or hub has certain benefits that areappealing for a variety of applications. It is common in the medicalfield that neural injection systems are inserted into patients for avariety of procedures. An issue that arises is how to secure orstabilize the neural injection system before, during and/or afterinsertion. A hemostat, pliers, and/or the like are often used to securean area about the connector to secure it, However, the use of ahemostat, pliers, and/or the like is capable of occluding visualizationdown and/or about the needle and/or catheter. Further, the use of anymetal tends to degrade the quality of images produced through NMR,X-ray, and/or the like. As well, the use of an instrument to secure theneedle that is capable of interfering with an image through or about theneedle is not desired in many applications. Accordingly, numerousprocedures, such as, but not limited to fluoroscopic guidanceprocedures, NMR procedures, X-ray procedures, direct viewing procedures,and/or the like would find a benefit in a single winged structure.Solutions in the art comprise attaching wings to the connector, in mostcases, two wings. However, the inventors are unaware of the art fieldcontaining a neural injection system comprising an elongated at leastpartially hollow shaft comprising a sharp needle at least partiallyoccluded, closed distal end; a connector end; and, at least one sideport located coaxially along the shaft, with a single wing. Doublewinged structures exist in the art, but are more expensive tomanufacture and the double wings do not add appreciable stability.Accordingly, benefits can be realized with a one winged design that canbe secured by a hemostat, pliers and or the like, without requiringbending or manipulation of the needle and/or any associated connectorand/or wing.

The inventor believes that the double winged structures were created sothat, among other attributes, medical personnel could stabilize theneedle by pinching the two wings together as the needle is inserted.However, pinching the two wings together creates inherent instability.

Various embodiments of the present invention further comprise a wire orother means of conveying stimulation to a target tissue. In anembodiment, the wire extends along the cannula from about the proximalend to the shoulder. In an alternate embodiment, the wire is integral(attached to) with the cannula. In an alternate embodiment, the wireextends along the outside of the cannula. In yet an alternateembodiment, a wire extends, along, through, and is integral with thestylet. No matter where the wire is contained or attached, it ispreferable to have the wire secured so that the wire is not loose.

Design considerations that are capable of being implemented with variousembodiments of the present invention include, but are not limited todesigning the wire and connector such that they may be utilized as aplug and use type of arrangement. A plug and use arrangement isbeneficial because it reduces the complexity of the device and reducesloose wires. In an embodiment, the wire is formed into the connectorsuch that when the connector is connected to another medical instrument,the wire is able to communicate with the instrument. However, anyconnection common in the art that would allow the wire to communicatewith a medical instrument is contemplated within the various embodimentsof the present invention.

Further modifications of embodiments of a neural injection system with awire comprise the introduction of insulation or at least one forminsulation about the cannula, stylet, and/or wire. In general any methodof insulation could be used such as, but not limited to, a plastic, ametal, and/or the like.

Further modifications of embodiments of a neural injection system with awire comprise the introduction of a probe about the shaft and/or wire.In general any method of insulation could be used as describedpreviously. Various probes capable of use with embodiments of thepresent invention include temperature probes, stimulation probes,cameras, and/or the like.

Accordingly, a further embodiment of the present invention comprises aneural injection system comprising an at least partially hollow cannulabeing defined by a first inside diameter, a first outside diameter, anda first length, and a side port located coaxially along the cannula forfluid communication from inside said at least partially hollow cannulato outside said at least partially cannula, wherein said cannula has arounded open blunt distal end; a stylet, wherein the stylet is capableof being releasably locked in a first position within said cannula; and,an introducer being defined by a second inside diameter, a secondoutside diameter, and a second length, wherein the introducer is usedfor access across a tissue of a patient that cannot be punctured by therounded open blunt distal end during a normal insertion procedure; and,a connector end connected through a connection to an instrument.

Also contemplated in various embodiments of the present invention aremethods of use and manufacture of a neural injection system of thepresent invention.

An exemplary embodiment of a method of the present invention comprises amethod for administering a medicament to a patient comprising the stepsof locating a site for injection; inserting at least a portion of aneural injection system into the site, the neural injection systemcomprising an at least partially hollow cannula being defined by a firstinside diameter, a first outside diameter, and a first length, and aside port located coaxially along the cannula for fluid communicationfrom inside said at least partially hollow cannula to outside said atleast partially hollow cannula, wherein said cannula has a rounded openblunt distal end; a stylet, wherein the stylet is capable of beingreleasably locked in a first position within said cannula; and,injecting the medicament into the patient. In an embodiment, themedicament is anesthesia. Further embodiments comprise the use of anintroducer, the introducer being defined by a second inside diameter, asecond outside diameter, and a second length, wherein the introducer isused for access across a tissue of a patient that cannot be punctured bythe rounded open blunt distal end during a normal insertion procedure.

Further embodiments of a method of the present invention furthercomprise stimulating a tissue. Yet further embodiments of a method ofthe present invention comprise ablating at least a portion of the tissueabout a site. Other embodiments comprise probing a tissue. And yetfurther embodiments of a method of the present invention comprisepreparing a patient for administering a medicament.

In an embodiment of an administration of a block, such as a nerve block,the method further comprises preparing the patient. In an embodiment,preparing the patient comprises placing a patient in a supine positionor extended position, without a pillow, with the patient's head in aneutral position.

In an embodiment of administration of a medicament, while standing onthe side of the body that is to be blocked, the physician tactilelylocates the cricoid cartilage. The neural injection system is theninserted in a position approximately one finger breadth below thecricoid cartilage, between the carotid sheath and the trachea on theside to be blocked, while aiming slightly medially until bony contact ismade with the ventral lateral side of the body of the seventh cervicalvertebra. When the neural injection system is in said position, theanesthesia is injected. The new design allows for directional injectionout the side port onto the surface of the anterior longitudinalligament. This allows the anesthesia to spread onto the surface of thelongus coli muscle toward the stellate ganglion. Thus, an injection viathe side port will achieve an effective stellate ganglion sympatheticblock.

In another embodiment according to the present invention, there areprovided methods for injecting a medicament into tissue in a subject inneed thereof. The invention injection method comprises inserting thedistal portion of an embodiment of the neural injection system into thetissue of the subject and causing a therapeutic amount of the medicamentto ooze multidirectionally from a distal end into the tissue withoutsubstantial leakage or loss of the medicament at the surface of thetissue. The invention method using the invention with a porous distalend is designed for injection of minute amounts of fluid into tissue ora body wall, hence the use of the term “microinjection” herein. However,other amounts may also be injected.

In an alternate embodiment according to the present invention, there areprovided methods for injecting a medicament into a subject in needthereof comprising inserting the distal portion of the neural injectionsystem into an interior body wall or tissue of the subject and applyingsufficient pressure to a liquid medicament in fluid communication withthe distal portion of the neural injection system to expel themedicament such that the medicament weeps multidirectionally from thepores in the distal end thereof into the interior body wall or tissuewithout substantial leakage or loss of the medicament at the surface ofthe body wall.

Various embodiments of the present methods are particularly useful forinjecting medicament(s) into an interior body wall or tissue that issubject to motion, for example, the wall of a beating heart duringelectrophysiologic testing, transmyocardial revascularization, and thelike. The blunt cannula reduces incidence of inadvertent puncture and/orprick.

In yet another embodiment, the present invention provides a method forinjecting a medicament into tissue in a subject in need thereofcomprising: inserting the distal portion of the invention system intothe tissue of the subject and causing a therapeutic amount of themedicament to ooze multidirectionally from the distal end into thetissue without substantial damage to the tissue of the subject caused byinjectate.

The invention may be embodied in other specific forms without departingfrom its spirit or essential characteristics. The described embodimentsare to be considered in all respects only as illustrative and notrestrictive. The scope of the invention is, therefore, indicated by theappended claims rather than by the foregoing description. All changes tothe claims which come within the meaning and range of equivalency of theclaims are to be embraced within their scope, Further, all publisheddocuments, patents, and applications mentioned herein are herebyincorporated by reference, as if presented in their entirety herein.

EXAMPLE

FIG. 1 illustrates a neural injection system 1 having a cannula 10, adistal portion 5, shoulder 3, a side port 7, and a stylet (not shown) 2.Cannula 10 is capable of being characterized by a distance from theabsolute tip of distal portion 5 to side port 7 and is represented bydistance 9. Distance 9 is about 1.1 mm in this embodiment. However,distance 9 is capable of being any distance as dictated by the procedureand/or patient. Distal portion 5 typically comprises a blunt portion 11and a stylet 2.

A neural injection system 1 of the present invention can be of anylength. In various embodiments, the length is the same or similar tothat of a 20 or a 22 gauge needle. A 20 gauge needle has an outsidediameter of about 0.0355 to 0.0360 mm and an inside diameter of about0.0230 to 0.0245 mm. A 22 gauge needle has an outside diameter of about0.0280 to 0.0205 mm and an inside diameter of about 0.0155 to 0.0170 mm.

Now referring to FIG. 2, a perspective view of the embodiment of FIG. 1,an arrangement of distal portion 5 becomes more apparent. In thisembodiment, distal portion 5 comprises a stylet 2 and blunt portion 11.Shoulder 3 is rounded such that there are no sharp edges. Stylet 2 andshoulder 3 are flush in this embodiment.

Now referring to FIG. 3, an embodiment of a neural injection system ofthe present invention is disclosed wherein side port 27 is quadrangular.

Now referring to FIG. 4, an illustration of an alternate embodiment of aneural injection system of the present invention is disclosed. Neuralinjection system 40 comprises a distal portion 45, cannula 50, and acircular side port 47, wherein distal portion 45 comprises a shoulder43, blunt portion 51, and stylet 48. In this embodiment, stylet 48 isnot flush with blunt portion 51. Stylet 48 extends past blunt portion51.

Now referring to FIG. 5, an illustration of a cross section of analternate embodiment of a neural injection system of the presentinvention is disclosed. Neural Injection System 60 comprises a distalportion 65, a cannula 75, a side port 70, an insulation 77, a wire 79, aconnector 72, a wing 76, and a medical instrument 74, wherein distalportion 65 comprises a stylet 71, a shoulder 63, and a blunt portion 71.Wire 79 is capable of treatment of a tissue. Insulation 77 assists inlocalizing treatment.

Now referring to FIG. 6, an illustration of an alternate embodiment of aneural injection system of the present invention is disclosed. Neuralinjection system 80 comprises a cannula 95, distal portion 85, a squareside port 90, a connector 92, a medical instrument 94, and at least twowings 96.

Now referring to FIG. 7, a cross-section of an alternate embodiment of aneural injection system of the present invention is disclosed. NeuralInjection system 100 comprises a distal portion 105, a stylet 107, acannula 115, an introducer 117, a housing 116, and a medical instrument114. Distal portion 105 comprises a stylet 107, comprising a solidportion 104 and a generally hollow portion 106.

Side port 110 is not visible in this embodiment, but has beenrepresented by dashed lines for illustration purposes. Side port 110generally extends across at least cannula 115 and a surface of stylet107. Therefore, stylet 107 comprises, in application, a side port acrosscannula 115 and a side port across stylet 107. In various embodiments,the side ports are positioned such that reasonable alignment of the sideports occurs at a desired position of the stylet within the cannula.

Housing 116 is at least partially capable of maintaining introducer 117.FIG. 7 illustrates an at least partially extended introducer 117.Introducer 117 has an edge 118 capable of penetrating a tissue.

Now referring to FIG. 8, an illustration of a distal portion of analternate embodiment of a neural injection system of the presentinvention is disclosed. Neural injection system 120 comprises a cannula137 and a stylet 127. Side port 130 has been represented by dashed linesfor illustrative purposes. In this embodiment, stylet 127 is capable ofbeing extended to contact a tissue wherein point 129 can penetrate thetissue, thereby removing the need for an introducer.

1. (canceled)
 2. (canceled)
 3. (canceled)
 4. (canceled)
 5. A neuralinjection system comprising: an at least partially hollow cannula beingdefined by a first inside diameter, a first outside diameter, and afirst length, and a side port located coaxially along the cannula forfluid communication from the inside said at least partially hollowcannula to outside said at least partially hollow cannula, wherein saidcannula has a rounded open blunt distal end; a stylet, wherein thestylet is capable of being releasably locked in a first position withinsaid cannula; and further wherein the stylet is an introducer capable ofaccess across a tissue of a patient that cannot be punctured by therounded open blunt distal end during a normal insertion procedure. 6.The neural injection system of claim 5, wherein the stylet furthercomprises a side port.
 7. The neural injection system of claim 5,wherein the stylet is retractable.